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Yesterday was a busy day of back to back presentations from the first day of the FDA hearings and there are many recaps now sharing some topline points from the conversations and presentations. I shared my own take on some big themes that emerged from the early part of the day here on this blog. Aside from the content presented during each of the speaker’s time on stage, I think there were several pivotal moments of significance throughout the day. Here’s a chronological recap of what I felt they were, and what they might mean for the next step of this process the FDA has just begun:

1. Pharma needs guidance (Eli Lilly) - Being the first real pharma brand to speak on the agenda, Michelle Sharp did an excellent job representing some of the main concerns that most pharma brands have. Her point that they were operating in a vacuum and therefore simply not willing to use the online channel was well presented. Ultimately, it was her presence and the comparative courage of Eli Lilly to have her on stage that truly stood out, particularly when you consider how many pharma brands were content to sit on the sidelines passively and simply watch the proceedings. continue reading

The much anticipated FDA hearings on how pharma and medical device companies should be able to use the Internet and social media for promotion kicked off today and the presentation room at the NTSB was packed with formally dressed people with expectant faces, ready to participate in what most people consider one of the most important moments in the history of online advertising and promotion in the medical space.

Based on the presentations this morning (including mine on behalf of Ogilvy) there were several themes that emerged as topics that will be interesting to track throughout the rest of the hearings and beyond. To a large degree, these were also the points that the FDA asked probing questions on after speakers were done presenting, which is an indication of what topics the agency considers to be most important as well. The speakers in the morning session included Ogilvy PR, Pew Prescription Project, Eli Lilly, PhRMA, Pharma Marketing News, IAB, VuMedi, WebMD and WEGO. Based on listening to those presentations, here are a few topline thoughts on implications and common themes that are emerging so far:

1. Good quality content for patients and HCPs from companies IS worthwhile and desired. Through the morning proceedings, everyone agreed that companies should have SOME ability to create and promote content online. This is an important agreement moving forward, as it assumes that the focus on future guidelines from the FDA will be about HOW companies can interact online and not on the broader question of IF they should even be allowed to. If there is one big conclusion that I hope the FDA takes away from today, it is that there is an important and meaningful place for pharma and medical device brands to share content and messages online, and this category of information should not be silenced completely or banned.

2. Doing nothing is not an option. A few speakers mentioned the same point this morning, that with the growing number of “unscrupulous” sources of medical information online from people such as “snake-oil salesman” promoting miracle cures, the necessity for the FDA to step forward and help to define what acceptable forms of marketing online are is vital.

3. Companies should not be responsible for policing the Internet. One of the most common questions that companies are asking is how deep they should need to go when it comes to finding and correcting bad information. While opinions on that point may vary, several people this morning mentioned the same point of view that companies should not have to police the entire Internet for bad information.

For the rest of today, you can watch the rest of the proceedings live at http://www.capitolconnection.net/capcon/fda/111209/FDAlive.htm.  Also, if you would like to read more about our POV that we presented today, including a summary of our “3 C’s” model for accountability, you can visit the following resources:

Ogilvy’s Presentations Today and Tomorrow at the FDA >>
Summary of Ogilvy’s 3 C’s Model For Accountability >>

Next week Ogilvy will be sharing our point of view when it comes to how pharmaceutical and medical device brands should be allowed to use the web and social media for marketing and promotion. This has been a significant gray area in the past and the FDA has begun the process towards having some updated guidelines set. We are one of over 60 organizations that will be speaking during the two day hearing next week, and the questions will range from everything to what information marketers should be allowed to link to, and how they should be held responsible for content online.

The biggest question that the entire process will raise is how to define the content, messages and conversations online that marketers should be held accountable by the FDA for. To answer this top question, we will be presenting our point of view through “The 3 C’s Rule” …

What do you think - does this “rule” go too far, or far enough towards helping define what messages marketers should be accountable for online? For more context, check our our full FDA presentations on Slideshare:

http://www.slideshare.net/ogilvypharma

Most marketers who have anything to do with promoting pharmaceutical products or medical devices have the upcoming FDA hearings at the top of this minds heading into next week.  With less than 7 days to go until the hearings, all the presentations have been submitted to the FDA, the anticipation is rising and conversation online about the hearings from speakers, attendees and online watchers (the hearings will be live webcast) is rising.

Ogilvy is among the organizations slated to speak at the hearings, and we have several activities planned around them beyond speaking - including hosting a “tweetup” the evening after the first hearing in our Washington DC office for anyone interested in coming and having an informal chat about how the day went and implications for our industry. In preparation for this moment, here are 5 things anyone in the industry should expect to come from the hearings, as well as some initial information you should know:

1. What is the format of the hearing? The entire hearing consists of short introductory remarks by the FDA followed by a series of 15 or 10 minute presentations by approved speakers. There are about 60 approved speakers and on Thursday they will all focus on answering the first four questions from the FDA hearing notice, and Friday morning will solely focus on “question #5′ which is about adverse event reporting online. Friday afternoon will continue general comments. Each presentation will be specifically cut off at the time alloted and the FDA panel hearing these presentations may choose to ask questions during a speaker’s alloted time. continue reading